KORU Medical Submits 510(k) for FreedomEDGE System with PHESGO Oncology Biologic Clearance

KORU Medical Systems submitted a 510(k) premarket notification to the FDA for the FreedomEDGE infusion system to subcutaneously administer PHESGO, a co-formulated therapy for HER2+ breast cancer. This milestone marks a key expansion of the FreedomEDGE system beyond its current immunoglobulin indications into the broader oncology infusion center market. The system is designed to address unmet needs related to nursing satisfaction with drug administration, enabling consistent, controlled large-volume SC delivery while supporting streamlined clinical workflows. KORU Medical anticipates market entry upon FDA 510(k) clearance.